Ocular Pressure Regulation

• US 20070106235A1
• Filed: 12/22/2006
• Published: 05/10/2007
• Est. Priority Date: 11/14/2003
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Transcend Medical Incorporated (Alcon Incorporated)
• Inventors: Coroneo, Minas
• Granted Patent: US 7,850,638 B2
• Time in Patent Office: Days
• US Class Current: 604/294
• CPC Class Codes: A61F 2/148 Implantation instruments specially adapted therefor
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

This invention comprises a flexible ocular device for implantation into the eye formed of a biocompatible elastomeric material, foldable to a diameter of 1.5 mm or less, comprising a fluid drainage tube having at one end a foldable plate adapted to locate the device on the inner surface of the sclera in a suprachoroidal space formed by cyclodialysis, said drainage tube opening onto the disc at one end and opening to the anterior chamber when implanted into the eye at its other end, so as to provide aqueous pressure regulation. Also provided are methods for the treatment of glaucoma utilising the flexible ocular device, and an ocular pressure spike shunt.

Claims

1. A method of placing an ocular device into the eye, comprising:

providing a fluid drainage tube having a first end and a second end;

forming a self-sealing incision in the cornea into the anterior chamber of the eye;

introducing the fluid drainage tube through the self-sealing incision and into the suprachoroidal space through a cyclodialysis created via a cannula; and

placing the fluid drainage tube such that when implanted into the eye the first end of the drainage tube opens into the suprachoroidal space and the second end of the drainage tube opens into the anterior chamber, so as to provide aqueous pressure regulation.

2. The method of claim 1, wherein the aqueous pressure of the eye is maintained at a pressure of not less than 10 mmHg.

3. The method of claim 1, wherein the step of forming a self-sealing incision is performed under direct visualization utilizing a gonioscopy lens.

4. The method of claim 1, wherein the step of introducing the fluid drainage tube into the suprachoroidal space is performed under direct visualization utilizing a gonioscopy lens.

5. The method of claim 1, wherein the self-sealing incision is created in the cornea 180 degrees away from a planned implant insertion site.

6. The method of claim 1, further comprising injecting a viscoelastic substance into the anterior chamber of the eye.

7. The method of claim 1, further comprising injecting a viscoelastic substance into the eye such that the substance extends into the suprachoroidal space to enlarge the cyclodialysis.

8. The method of claim 1, further comprising applying laser energy to the trabecular meshwork of the eye during the procedure method provided herein.

9. A method of placing an ocular device into the eye, comprising:

providing an ocular instrument having a tip;

providing a fluid drainage tube having a distal portion and a proximal portion;

forming an incision in the cornea into the anterior chamber of the eye;

pushing the tip of the ocular instrument into an angle between the iris and the cornea and into a space between the ciliary body and sclera; and

deploying the fluid drainage tube through the space created by the tip of the ocular instrument by advancing the drainage tube such that the distal portion of the drainage tube opens into the suprachoroidal space and the proximal portion of the drainage tube opens into the anterior chamber when implanted into the eye.

10. The method of claim 9, wherein forming an incision comprises an incision that is self-sealing.

11. The method of claim 9, wherein forming an incision comprises an incision formed using the tip of the ocular instrument.

12. The method of claim 9, wherein forming an incision comprises an incision formed by a tip of the fluid drainage tube.

13. The method of claim 9, wherein the fluid drainage tube proximal portion is cut to size once it is in the anterior chamber.

14. The method of claim 9, wherein the fluid drainage tube operates to regulate the aqueous pressure of the eye.

15. The method of claim 9, wherein the aqueous pressure of the eye is maintained at a pressure of not less than 10 mmHg.

16. The method of claim 9, wherein the step of forming an incision is performed under direct visualization utilizing a gonioscopy lens.

17. The method of claim 9, wherein the step of introducing the fluid drainage tube into the suprachoroidal space is performed under direct visualization utilizing a gonioscopy lens.

18. The method of claim 9, wherein the incision is created in the cornea 180 degrees away from the planned implant insertion site.

19. The method of claim 9, further comprising injecting a viscoelastic substance into the anterior chamber of the eye.

20. The method of claim 9, further comprising applying laser energy to the trabecular meshwork of the eye during the procedure method provided herein.

21. A method of placing an ocular device into the eye, comprising:

forming an incision in the cornea to provide an opening into an anterior chamber of the eye;

inserting a fluid drainage tube into the anterior chamber through the opening;

pushing a tip of the ocular instrument into an angle between the iris and the cornea and into a space between the ciliary body and the sclera; and

placing the fluid drainage tube in a position in the eye so that a first end of the tube communicates with the anterior chamber and a second end of the tube communicates with the suprachoroidal space, the tube providing a fluid flow pathway between the anterior chamber and the suprachoroidal space.

22. The method of claim 21, wherein placing a fluid drainage tube comprises positioning an anchor in the suprachoroidal space so as to keep the fluid drainage tube in the position.

23. The method of claim 22, wherein the anchor is a plate.

24. The method of claim 22, wherein the anchor has a shape that matches the curvature of the eye.

25. The method of claim 22, wherein the anchor is foldable.

26. The method of claim 21, wherein forming an incision comprises an incision that is self-sealing.

27. The method of claim 21, wherein forming an incision comprises an incision formed in the limbus of the eye.

28. The method of claim 21, further comprising performing a cyclodialysis in the eye.

29. The method of claim 21, further comprising inserting the fluid drainage tube into the anterior chamber via a cannula.

30. A method of placing an ocular device into the eye, comprising:

providing a fluid flow member having a fluid flow passageway and a positioning element adapted to locate the fluid flow member on the inner surface of the sclera in the suprachoroidal space;

inserting the fluid flow member into the anterior chamber through a self-sealing incision in the cornea;

guiding the fluid flow member along a pathway that passes through an angle between the iris and the cornea; and

inserting the positioning element of the fluid flow member in the suprachoroidal space such that the fluid flow passageway fluidly couples the anterior chamber and the suprachoroidal space.

31. The method of claim 30, wherein inserting the fluid flow member comprises inserting through the self-sealing incision while the positioning element is in a folded state and wherein the positioning element unfolds to an unfolded state while in the suprachoroidal space.

32. The method of claim 30, wherein the positioning element unfolds into a shape that matches the curvature of the eye.

33. The method of claim 30, wherein the positioning element is a plate.

34. The method of claim 30, wherein the positioning element keeps the fluid flow member in a position in the eye.

35. The method of claim 30, wherein the fluid flow member provides aqueous pressure regulation to maintain the aqueous pressure of the eye at a pressure of not less than 10 mmHg.

36. The method of claim 30, further comprising forming the self-sealing incision under direct visualization utilizing a gonioscopy lens.

37. The method of claim 30, wherein the fluid flow member is guided along the pathway under direct visualization utilizing a gonioscopy lens.

38. The method of claim 30, wherein the self-sealing incision is created in the cornea 180 degrees away from a planned implant insertion site.

39. The method of claim 30, further comprising injecting a viscoelastic substance into the anterior chamber of the eye.

40. The method of claim 30, further comprising injecting a viscoelastic substance such that it extends into the suprachoroidal space to enlarge a cyclodialysis.

41. The method of claim 30, further comprising applying laser energy to the trabecular meshwork of the eye during the procedure method provided herein.

42. A method of placing an ocular device into the eye, comprising:

providing a fluid drainage tube having a foldable anchor member;

forming an incision to provide an opening into the anterior chamber of the eye;

forming an opening into the suprachoroidal space;

inserting a fluid drainage tube with the anchor member in a folded state into the anterior chamber through the incision and into the suprachoroidal space through the opening; and

unfolding the anchor member while the anchor member is in the suprachoroidal space so that the anchor keeps the fluid drainage tube in a position that provides a fluid passageway between the anterior chamber and the suprachoroidal space.

43. The method of claim 42, wherein unfolding the anchor member comprises unfolding to a size that keeps the anchor from falling out of the opening into which it was introduced into the suprachoroidal space.

44. The method of claim 42, wherein forming an incision comprises an incision that is self-sealing.

45. The method of claim 42, wherein the anchor member is a plate.

46. The method of claim 42, wherein the anchor member has a shape that matches the curvature of the eye.

47. The method of claim 42, wherein forming an incision comprises an incision that is formed in the limbus of the eye.

48. The method of claim 42, further comprising performing a cyclodialysis in the eye.

49. The method of claim 42, further comprising inserting the fluid drainage tube into the suprachoroidal space via a cannula.

50. A method of placing an ocular device into the eye, comprising:

forming a cyclodialysis in the eye;

inserting a fluid drainage tube through the cyclodialysis via a transcorneal approach into the eye; and

implanting the fluid drainage tube in the eye such that a first end of the fluid drainage tube is located within the suprachoroidal space on an inner surface of the sclera, wherein the first end of the drainage tube opens into the suprachoroidal space and a second end of the drainage tube opens into the anterior chamber when implanted into the eye, so as to provide aqueous pressure regulation.

51. The method of claim 50, wherein the cyclodialysis is formed using a cannula inserted into the eye and through the angle between the iris and the cornea and into the space between the ciliary body and the sclera.

52. The method of claim 50, wherein the fluid drainage tube is introduced using a cannula inserted into the eye.

53. The method of claim 50, wherein inserting a fluid drainage tube comprises inserting the tube while in a first state of reduced size.

54. The method of claim 50, wherein the fluid drainage tube includes an anchor that is positioned in the suprachoroidal space so as to keep the fluid drainage tube in the position.

55. The method of claim 54, wherein the anchor is a plate.

56. The method of claim 54, wherein the anchor has a shape that matches the curvature of the eye.

57. The method of claim 54, wherein the anchor is foldable.